Commerce

Re-establishing the Sanctuary Nomination Process

AGENCY: Office of National Marine Sanctuaries (ONMS), National Ocean
Service, National Oceanic and Atmospheric Administration (NOAA),
Department of Commerce (DOC).

ACTION: Proposed rule; request for public comments.

SUMMARY: NOAA's ONMS is announcing that it is re-establishing the
sanctuary nomination process and is proposing to amend its regulations
governing the process for nominating and evaluating sites for
eligibility as a national marine sanctuary. This action would replace
the currently inactive Sanctuary Evaluation List (SEL) with a new
process for local communities and other interested parties to provide
NOAA with robust, criteria-driven proposals for new national marine
sanctuaries. To implement this process, NOAA is seeking public comment
on proposed changes to the sanctuary nomination and designation
procedures, and on the criteria by which the agency would analyze
nominations for potential new national marine sanctuaries. Once these
criteria have been made final, NOAA intends to solicit nominations for
areas of the marine and Great Lakes environments that satisfy those
criteria for possible designation as a national marine sanctuary.

DATES: Comments on this proposed rule must be received no later than
August 27, 2013.

ADDRESSES: You may submit comments, identified by RIN 0648-BD20, by any
one of the following methods:

All comments received are a part of the public record and will be
posted to http://www.regulations.gov without change. All Personal
Identifying Information (for example, name, address, etc.) voluntarily
submitted by the commenter may be publicly accessible. Do not submit
confidential business information or otherwise sensitive or protected
information. ONMS will accept anonymous comments (for electronic
comments submitted through the Federal eRulemaking Portal, enter N/A in
the required fields if you wish to remain anonymous). Attachments to
electronic comments will be accepted in Microsoft Word, Excel,
WordPerfect, or Adobe PDF file formats only.

Science Advisory Board (SAB)

AGENCY: Office of Oceanic and Atmospheric Research (OAR), National
Oceanic and Atmospheric Administration (NOAA), Department of Commerce
(DOC).

ACTION: Notice of Open Meeting.

SUMMARY: The Science Advisory Board (SAB) was established by a Decision
Memorandum dated September 25, 1997, and is the only Federal Advisory
Committee with responsibility to advise the Under Secretary of Commerce
for Oceans and Atmosphere on strategies for research, education, and
application of science to operations and information services. SAB
activities and advice provide necessary input to ensure that National
Oceanic and Atmospheric Administration (NOAA) science programs are of
the highest quality and provide optimal support to resource management.

Time and Date: The meeting will be held Tuesday, July 23, 2013 from
2:00 p.m. to 5:00 p.m. EDT and Wednesday, July 24, 2013 from 1:00 p.m.
to 4:05 p.m. EDT. These times and the agenda topics described below are
subject to change. Please refer to the Web page http://www.sab.noaa.gov/Meetings/meetings.html for the most up-to-date meeting
agenda.

Place: Conference call. Public access is available at 1315 East-
West Highway, Room 11836 in Silver Spring, MD. Please check the SAB Web
site http://www.sab.noaa.gov/Meetings/meetings.html for address and
directions to the meeting location. Members of the public will not be
able to dial in to this meeting.

Status: The meeting will be open to public participation with a 10
minute public comment period on July 24 from 1:05-1:15 p.m. (check Web
site to confirm time). The SAB expects that public statements presented
at its meetings will not be repetitive of previously submitted verbal
or written statements. In general, each individual or group making a
verbal presentation will be limited to a total time of two (2) minutes.
Individuals or groups planning to make a verbal presentation should
contact the SAB Executive Director by July 17, 2013 to schedule their
presentation. Written comments should be received in the SAB Executive
Director's Office by July 17, 2013 to provide sufficient time for SAB
review. Written comments received by the SAB Executive Director after
July 17, 2013 will be distributed to the SAB, but may not be reviewed
prior to the meeting date. Seating at the meeting will be available on
a first-come, first-served basis.

Special Accommodations: These meetings are physically accessible to
people with disabilities. Requests for special accommodations may be
directed no later than 12 p.m. on July 17, 2013, to Dr. Cynthia Decker,
SAB Executive Director, SSMC3, Room
11230, 1315 East-West Hwy., Silver Spring, MD 20910.

Matters To Be Considered: The meeting will include the following
topics: (1) NOAA Response to the SAB Review of the Ocean Exploration
and Research Program; (2) NOAA Social Science Needs Assessment; (3)
Terms of Reference and Membership Approach for Gulf Coast Ecosystem
Restoration Science Program Advisory Working Group; (4) National
Academy of Public Administration Report: Forecasting the Future-
Assuring the Capacity of the National Weather Service; (5) Arctic
Policy and Management; (6) Arctic Science; (7) Climate Working Group-
Proposed Change in Terms of Reference and Working Group Update; (8)
Ecosystem Sciences and Management Working Group-Proposed New Member and
Working Group Update; (9) Environmental Information Services Working
Group-Membership and Working Group Update; and (10) Updates from Data
Archive and Access Requirements and Ocean Exploration Advisory Working
Groups.

DATES: Interested persons are invited to submit comments on or before
August 27, 2013.

ADDRESSES: Comments submitted in response to this notice should be
submitted electronically through the Federal eRulemaking Portal at
http://www.regulations.gov by selecting Docket ID number ED-2013-ICCD-
0087 or via postal mail, commercial delivery, or hand delivery. Please
note that comments submitted by fax or email and those submitted after
the comment period will not be accepted. Written requests for
information or comments submitted by postal mail or delivery should be
addressed to the Director of the Information Collection Clearance
Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ,
Room 2E105, Washington, DC 20202-4537.

FOR FURTHER INFORMATION CONTACT: Electronically mail
ICDocketMgr@ed.gov. Please do not send comments here.

Health and Human Services

Notice of a Department of Health and Human Services Public Meeting and Request for Comments on Matters Related to the Protection of Human Subjects and Research Studying Standard of Care Interventions

AGENCY: Office of the Secretary, Department of Health and Human
Services.

ACTION: Notice of meeting and request for comments.

SUMMARY: The Department of Health and Human Services (HHS) is
announcing a public meeting to seek public input and comment on how
certain provisions of the HHS requirements related to the protection of
human subjects should be applied to research studying one or more
interventions which are used as standard of care treatment in the non-
research context. HHS specifically is requesting input regarding how an
institutional review board (IRB) should assess the risks of research
involving randomization to one or more treatments within the standard
of care for particular interventions, and what reasonably foreseeable
risks of the research should be disclosed to research subjects in the
informed consent process. HHS is seeking participation in the meeting
and written comments from all interested parties, including, but not
limited to, IRB members, IRB staff, institutional officials, research
institutions, investigators, research subject advocacy groups,
ethicists, and the regulated community at large. This meeting and the
written comments are intended to assist HHS, through the Office for
Human Research Protections (OHRP), Office of the Assistant Secretary
for Health (OASH), in developing guidance regarding what constitutes
reasonably foreseeable risk in research involving standard of care
interventions such that the risk is required to be disclosed to
research subjects. HHS is seeking input on a number of specific
questions but is interested in any other pertinent information
participants in the public meeting would like to share.

DATES: Meeting: The public meeting will be held on August 28, 2013,
from 9 a.m. to 5 p.m.

Deadline for Registration for Participants (not Presenting) at the
Public Meeting and Submitting Requests for Special Accommodations:
Registration to attend the public meeting and requests for special
accommodations must be received no later than 5 p.m. on August 14,
2013.

Deadline for Registration of Presenters at the Public Meeting:
Registration to present at the public meeting must be received no later
than 5 p.m. on August 7, 2013.

Deadline for Submission of Written Comments for the Public Meeting:
Written comments for discussion at the public meeting must be received
no later than 5 p.m. on August 7, 2013. In addition to materials
submitted for discussion at the public meeting, individuals may submit
other written comments after the public meeting, as specified in the
ADDRESSES section of this notice. These comments must be received no
later than 5 p.m. on September 9, 2013, for consideration by HHS.

ADDRESSES: The Public Meeting will be held at the Department of Health
and Human Services, Hubert H. Humphrey Building, 200 Independence Ave.
SW., Great Hall, Washington, DC 20201; Metro: Federal Center SW
station.

In addition, we are providing an alternative to attending the
meeting in person; participants may view the public meeting via live
streaming technology. Information on that option is provided in section
II.D. of this notice.

Registration and Special Accommodations: While there is no
registration fee, individuals planning to attend the public meeting in
person must register to attend. Registration may be completed by
sending an email to OHRP@hhs.gov, with the subject line "Registration
for HHS Public Meeting''; or a request to register may be sent to:
Registration for HHS Public Meeting, Office for Human Research
Protections, Department of Health and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville, MD 20852. Please include your name,
address, telephone number, email address, and fax number. If you would
like to present at the public meeting, please state this in the
registration submission.

Registration to attend the public meeting will be accepted on a
first-come, first-served basis. If seating capacity has been reached,
you will be notified that the meeting has reached capacity.

Registration to present at the public meeting will be accepted on a
first-come, first-served basis. HHS has included questions for comment
in section III of this document. Please identify by number each
question you wish to address in your presentation and the approximate
time requested. HHS will do its best to accommodate requests to speak.
HHS will determine the amount of time allotted to each presenter and
the approximate time that each oral presentation is scheduled to begin.
Once HHS notifies registered presenters of their scheduled times,
presenters should submit a copy of each presentation, identified with
docket number HHS-OPHS-2013-0004, to http://www.regulations.gov.

Individuals who need special accommodations should contact staff
listed in the FOR FURTHER INFORMATION CONTACT section of this notice.